Multinational pharmaceutical, biotechnology and medical technologies company Johnson & Johnson (NYSE: JNJ) announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for its TREMFYA (guselkumab) intended to treat adults with moderately to severely active ulcerative colitis (UC).

The product is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23.

The approval of the product is based on data from a pivotal, ongoing Phase 2b/3 QUASAR study assessing the efficacy and safety of TREMFYA in adult patients who experienced an inadequate response or who showcase intolerance to conventional therapy, other biologics and/or JAK inhibitors.

David T Rubin, MD, director, Inflammatory Bowel Disease Center, University of Chicago Medicine and lead investigator for the QUASAR programme, said, 'Treatment with TREMFYA resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining. Today's approval of TREMFYA builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease.'